Department of Health and Human Services April 2007 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 311
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines
HRSA is soliciting comments on the proposed eligibility criteria for the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donations Program. Eligibility criteria were proposed by the program grantee, the Regents of the University of Michigan, to HRSA. HRSA has determined that the proposed eligibility criteria constitute a proper interpretation of the authorizing statute's requirements, including determinations as to which individuals would otherwise be unable to meet the eligible expenses authorized under this Program. HRSA is soliciting public comment on the criteria outlined in this notice. HRSA will consider the comments in light of the authorizing statute and seek feedback from the Regents of the University of Michigan concerning the comments. HRSA will then approve final criteria. The final program eligibility criteria will be posted on the Reimbursement of Travel and Subsistence Expenses for Living Organ Donation Web site, https://www.livingdonorassistance.org.
Draft Guidance for Clinical Investigators, Sponsors, and Investigational Review Boards on Adverse Event Reporting-Improving Human Subject Protection; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting Improving Human Subject Protection.'' This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the Institutional Review Board (IRB). FDA developed this draft guidance in response to concerns raised by the IRB community that increasingly large volumes of individual adverse event reports are inhibiting rather than enhancing IRBs' ability to adequately protect human subjects. The guidance provides recommendations to IRBs, sponsors, and investigators on improving the usefulness of the adverse event information submitted to IRBs.
Trimethobenzamide Hydrochloride Suppositories; Withdrawal of Approval
The Food and Drug Administration (FDA) is announcing the resolution of issues concerning trimethobenzamide hydrochloride suppositories. This notice announces the withdrawal of approval of the new drug application (NDA) for Tigan (trimethobenzamide hydrochloride) Suppositories. The notice also declares that the marketing of unapproved trimethobenzamide hydrochloride suppository products is unlawful and subject to FDA regulatory action. FDA is taking these actions because trimethobenzamide hydrochloride suppositories lack substantial evidence of effectiveness.
Draft Guidance for Industry on Orally Disintegrating Tablets; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Orally Disintegrating Tablets.'' The draft guidance provides pharmaceutical manufacturers of new and generic drug products with an agency perspective on the definition of an orally disintegrating tablet (ODT) and also provides recommendations to applicants who would like to designate a proposed product as an ODT.
Draft Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Dosage and Administration Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This draft guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear and accessible and complying with the new requirements in the final rule on the content and format of labeling for prescription drug and biological products (71 FR 3922, January 24, 2006). This draft guidance is intended to help applicants select information for inclusion in the ``Dosage and Administration'' section of labeling and to help them organize that information.
Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is announcing a public hearing to obtain feedback on FDA's Medication Guide program, which provides for the distribution of FDA-approved written patient information for certain drug and biological products that pose serious and significant public health concerns. FDA is interested in obtaining public comment on ways to improve communication to patients who receive Medication Guides. The purpose of the public hearing is to solicit information and views from interested persons on specific issues associated with the development, distribution, comprehensibility, and accessibility of Medication Guides, which are required to convey risk information to patients. Dates and Times: The public hearing will be held on June 12 and 13, 2007, from 8:30 a.m. to 4:30 p.m. on both days. Submit written or electronic notices of participation by 4:30 p.m. on May 12, 2007. Written and electronic comments will be accepted until July 12, 2007. Location: The public hearing will be held at the National Transportation and Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594 (Metro: L'Enfant Plaza Station on the Green, Yellow, Blue, and Orange Lines). Addresses: Submit written or electronic notices of participation to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or on the Internet at https://www.accessdata.fda.gov/scripts/oc/dockets/ meetings/meetingdocket.cfm. Submit written or electronic comments to https://www.accessdata.fda.gov/scripts/oc/dockets/commentdocke t.cfm or to the Division of Dockets Management. Transcripts of the hearing will be available for review at the Division of Dockets Management and on the Internet at https://www.fda.gov/ohrms/dockets approximately 21 days after the hearing. For Registration to Attend and/or to Participate in the Meeting: Seating at the meeting is limited. People interested in attending should register at https://www.accessdata.fda.gov/scripts/oc/dockets/ meetings/meetingdocket.cfm or submit a written request for registration to the Division of Dockets Management (see Addresses) by 4:30 p.m. on May 12, 2007. Registration is free and will be on a first-come, first- served basis. If you wish to make an oral presentation during the open session of the meeting, you must state this intention on your notice of participation (see Addresses) and provide an abstract of your presentation by May 12, 2007. In the notice, submit your name, title, business affiliation, address, telephone and fax numbers, and e-mail address. FDA has identified questions and subject matter of special interest in section II of this document. You should also identify the subject matter and question number you wish to address in your presentation, and the approximate time requested for your presentation. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and to request time for a joint presentation. FDA may require joint presentations by persons with common interests. We will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. You must submit final electronic presentations, if any, to Mary Gross (see Contacts) by no later than June 6, 2007. Contacts: Mary C. Gross, Safety Policy and Communication Staff (HFD-001), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5421, e-mail: mary.gross@fda.hhs.gov.
Medical Devices; Technical Amendment
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct typographical errors and to ensure accuracy and clarity in the agency's regulations.
Public Awareness of Embryo Donation and/or Adoption Public Awareness Campaign
The Office of Population Affairs (OPA), within the Office of Public Health and Science (OPHS) announces the availability of Fiscal Year (FY) 2007 funds to support a total of four to five new cooperative agreement projects, with the goal of increasing public awareness of embryo donation and/or adoption. OPA anticipates approximately $1,000,000 in funding will be available for four to five new cooperative agreements each in the range of $250,000 to $350,000 per year. Projects will be funded in annual increments (budget periods) and for a project period of two years. Funding for all budget periods beyond the first year of the cooperative agreement is contingent upon the availability of funds, satisfactory progress of the project, and adequate stewardship of Federal funds. Applicants must demonstrate experience with embryo donation and/or adoption programs that conform with professionally recognized standards governing embryo donation and/ or adoption and other applicable Federal or State requirements. For the purposes of this announcement, embryo donation and/or adoption is defined as the donation of frozen embryo(s) from one party to a recipient who wishes to bear and raise a child or children.
Notice of Availability of Draft Policy Document for Comment
HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of primary health care programs, including the Health Center Program. Therefore, we are requesting comments on the PIN referenced above. After review and consideration of all comments received, the PIN may be amended to incorporate certain recommendations from the public. Once the PIN is finalized, it will be made available on HRSA's Web site, along with the Agency's ``Response to Public Comments.'' That document will summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PIN. Where comments do not result in a revision to the PIN, explanations will be provided.
Notice of Meeting of the Advisory Committee on Organ Transplantation
Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the twelfth meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on May 15, 2007, and from 9 a.m. to 3 p.m. on May 16, 2007, at the DoubleTree Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).
Notice of Hearing: Reconsideration of Disapproval of Minnesota State Plan Amendment 05-10
This notice announces an administrative hearing to be held on May 30, 2007, at 233 N. Michigan Avenue, Suite 600, the Indiana Room, Chicago, IL 60601, to reconsider CMS' decision to disapprove Minnesota State plan amendment 05-10.
Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (formerly called Advisory Committee for Pharmaceutical Science); Notice of Meeting; Cancellation
The meeting of the Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology scheduled for April 30, 2007, is cancelled. This meeting was announced in the Federal Register of March 5, 2007 (72 FR 9767).
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (formerly called Advisory Committee for Pharmaceutical Science); Notice of Meeting; Cancellation
The meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology scheduled for May 1 and 2, 2007, is cancelled. This meeting was announced in the Federal Register of March 16, 2007 (72 FR 12621).
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